FDA.reportPublic FDA data

DAKO NORTH AMERICA, INC.

Matched from indexed company URL: DAKO CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20221802022180DAKO NORTH AMERICA, INC.1Y2020-04-256392 VIA REAL CARPINTERIA CA US 93013
96100993002806778DAKO DENMARK ApS1N2020-04-2542 PRODUKTIONSVEJ GLOSTRUP Region Hovedstaden DK DK-2600
30130596833013059683Dako Logistics Company ApS1N2020-04-2542 PRODUKTIONSVEJ -- GLOSTRUP DK DK-2600

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05700571105368Fragile X Fluorescein-Labelled Probe - Y1442+1-805-566-6655dako.usregulatory@agilent.com
05700571112465User-Fillable Reagent Bottle 5mL Capacity (Link) - SK200+1-805-566-6655dako.usregulatory@agilent.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
132211096459163P980018DAKO HERCEPTESTMVC1998-09-25
2309271096459163P980018DAKO HERCEPTESTMVC1998-09-25
132201899769849P150025PD-L1 IHC 28-8 pharmDx2015-10-09
132211899769849P150025PD-L1 IHC 28-8 pharmDx2015-10-09
132202020266277P150013PD-L1 IHC 22C3 PHARMDXPLS2015-10-02
132212020266277P150013PD-L1 IHC 22C3 PHARMDXPLS2015-10-02
2309272020266277P150013PD-L1 IHC 22C3 PHARMDXPLS2015-10-02
132211988166467P040005DAKOCYTOMATION HER2 FISH PHARMDX KITMVD2005-05-03
2309271988166467P040005DAKOCYTOMATION HER2 FISH PHARMDX KITMVD2005-05-03
132201624158755P030044DAKOCYTOMATION EGFR PHARMDXNQF2004-02-12
132211624158755P030044DAKOCYTOMATION EGFR PHARMDXNQF2004-02-12
132211469930849K991454MOUSE IGG1 NEGATIVE CONTROLSGKZ1999-06-21
2309271469930849K991454MOUSE IGG1 NEGATIVE CONTROLSGKZ1999-06-21
132211149814293K991402DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1GKZ1999-06-21
2309271149814293K991402DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1GKZ1999-06-21
132201111735081K984188AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)JOY1999-07-28
132211111735081K984188AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)JOY1999-07-28
132211978063922K980635DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37GKZ1998-07-22
2309271978063922K980635DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37GKZ1998-07-22
132212010723569K964974MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPEGKZ1997-06-24
2309272010723569K964974MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPEGKZ1997-06-24
132211633845650K960887MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPEGKZ1996-05-17
2309271633845650K960887MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPEGKZ1996-05-17
132211816987407K960531MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPEGKZ1996-06-14
2309271816987407K960531MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPEGKZ1996-06-14
132211093767251K945212MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/GKZ1996-01-26
2309271093767251K945212MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/GKZ1996-01-26
132211921434647K944253MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25GKZ1994-11-21
2309271921434647K944253MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25GKZ1994-11-21
132211727241942K943284MONOCLONAL MOUSE ANTI-HUMAN B-CELLGKZ1994-11-21
2309271727241942K943284MONOCLONAL MOUSE ANTI-HUMAN B-CELLGKZ1994-11-21
132211940599156K942797MONOCLONAL MOUSE ANTI-HUMAN T-CELLGKZ1994-11-10
2309271940599156K942797MONOCLONAL MOUSE ANTI-HUMAN T-CELLGKZ1994-11-10
132211009794559K931192DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODYDEH1995-04-20
2309271009794559K931192DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODYDEH1995-04-20
132211546391054K831909RABBIT ANTISERUM TO HUMAN IGACZN1983-07-18
2309271546391054K831909RABBIT ANTISERUM TO HUMAN IGACZN1983-07-18
132211053461451K831908RABBIT ANTISERUM TO HUMAN IGGDGK1983-07-18
2309271053461451K831908RABBIT ANTISERUM TO HUMAN IGGDGK1983-07-18
132212012365031K831907RABBIT ANTISERUM TO HUMAN IGMDFS1983-07-19
2309272012365031K831907RABBIT ANTISERUM TO HUMAN IGMDFS1983-07-19
132211672435095K831906RABBIT ANTISERUM TO HUMAN C4DBI1983-07-19
2309271672435095K831906RABBIT ANTISERUM TO HUMAN C4DBI1983-07-19
132211798203834K831905RABBITT ANTISERUM TO HUMAN C3CCZW1983-07-18
2309271798203834K831905RABBITT ANTISERUM TO HUMAN C3CCZW1983-07-18
132211881265955K831904RABBIT ANTISERUM TO HUMAN KAPPA LIGHTDEO1983-07-19
2309271881265955K831904RABBIT ANTISERUM TO HUMAN KAPPA LIGHTDEO1983-07-19
132211133995698K831903FLUORESCEIN CONJUGATED IMMUNOGLOBULINDES1983-07-19
2309271133995698K831903FLUORESCEIN CONJUGATED IMMUNOGLOBULINDES1983-07-19
132211419908806K831902FLUORESCEIN CONJUGATED IMMUNOGLOBIN-DDZ1983-07-18
2309271419908806K831902FLUORESCEIN CONJUGATED IMMUNOGLOBIN-DDZ1983-07-18
132211179154956K812662IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDADEH1981-09-29
2309271179154956K812662IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDADEH1981-09-29
132211470469399K812661IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPADFH1981-09-29
2309271470469399K812661IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPADFH1981-09-29
132211786834201K812495IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHADEW1981-09-23
2309271786834201K812495IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHADEW1981-09-23
132211104159323K812489IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGGDEW1981-09-23
2309271104159323K812489IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGGDEW1981-09-23
132211936952340K812488IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGACZP1981-09-23
2309271936952340K812488IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGACZP1981-09-23
132211967631211K812487IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGMDAO1981-09-23
2309271967631211K812487IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGMDAO1981-09-23
132201158874605K170028FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)MYA2017-12-21
132211158874605K170028FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)MYA2017-12-21
132201386555872K170005FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)MXZ2017-12-21
132211386555872K170005FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)MXZ2017-12-21
132201402099505K130861MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)MXZ2013-12-09
132211402099505K130861MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)MXZ2013-12-09
2309271402099505K130861MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)MXZ2013-12-09
132201349533719K120663MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPIMYA2013-02-12
132211349533719K120663MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPIMYA2013-02-12
2309271349533719K120663MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPIMYA2013-02-12
132201618722967K042884DAKOCYTOMATION ER/PR PHARMDX KITMXZ2005-02-15
132211618722967K042884DAKOCYTOMATION ER/PR PHARMDX KITMXZ2005-02-15
2309271618722967K042884DAKOCYTOMATION ER/PR PHARMDX KITMXZ2005-02-15
132211737491791K041627CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATORNDY2004-09-03
2309271737491791K041627CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATORNDY2004-09-03
132211485778360K032692DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368JZG2004-01-22
2309271485778360K032692DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368JZG2004-01-22
132201411526028K032113ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)NOT2003-12-23
132211411526028K032113ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)NOT2003-12-23
132201658671774K020023DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAININGMXZ2002-02-28
132211658671774K020023DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAININGMXZ2002-02-28
2309271658671774K020023DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAININGMXZ2002-02-28
132201033313466
132211033313466
132201067474226
132211067474226
132201068501444
132211068501444
2309271068501444
132201130233038
132211130233038
2309271130233038
132211143532930
2309271143532930
132211191195238
2309271191195238
132201210967490
132211210967490
132201249787114
132211249787114
132201287783166
132211287783166
2309271287783166
132211340911345
2309271340911345
132211351231362
2309271351231362
132201359362217
132211359362217
132211368599224
2309271368599224
132201371057551
132211371057551
2309271371057551
132201377051165
132211377051165
132201413581631

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GKZ201999-06-21
MXZ112017-12-21
MYA52017-12-21
PLS52015-10-09
DEH41995-04-20
DEW41981-09-23
MVD22005-05-03
NDY22004-09-03
NQF22004-02-12
JZG22004-01-22
NOT22003-12-23
JOY21999-07-28
MVC21998-09-25
DEO21983-07-19
DFS21983-07-19
DES21983-07-19
DBI21983-07-19
DDZ21983-07-18
CZW21983-07-18
DGK21983-07-18
CZN21983-07-18
DFH21981-09-29
CZP21981-09-23
DAO21981-09-23

PMA#

108 records. Showing 1-40. Next

PMN#

IMAGEN

1995-01-09

DAKO DIAGNOSTICS LTD.

72 records. Showing 1-40. Next

GUDID#